RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR- nicotine polacrilex gum, chewing

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
REMEDYREPACK INC.
Administration route:
BUCCAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid - reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking - a sodium-restricted diet - heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. - high blood pressure not controlled with medication. Nicotine can increase blood pressure. - stomach ulcer or diabetes - history of seizures - using a non-nicotine stop smoking drug - taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.  - mouth, teeth, or jaw problems occur - irregular heartbeat or palpitations occur - you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat - you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Product summary:
Nicotine Gum 4mg Gum. square, white (off white to tan), Mint, 14mm, no score, no imprint NDC: 70518-1048-00 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-1048-0

RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR- nicotine polacrilex gum, chewing

REMEDYREPACK INC.

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Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care

provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine

replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your

child from this medicine are not fully known.

Ask a doctor before use if you have

a sodium-restricted diet

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

high blood pressure not controlled with medication. Nicotine can increase blood pressure.

stomach ulcer or diabetes

history of seizures

Ask a doctor or pharmacist before use if you are

using a non-nicotine stop smoking drug

taking prescription medicine for depression or asthma. Your prescription dose may need to be

adjusted.

Stop use and ask a doctor if

mouth, teeth, or jaw problems occur

irregular heartbeat or palpitations occur

you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and

rapid heartbeat

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of

gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison

Control Center right away.

Directions - 2 mg

if you are under 18 years of age, ask a doctor before use

before using this product, read the enclosed User's Guide for complete directions and other

important information

begin using the gum on your quit day

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum

according to the following 12 week schedule:

Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours

nicotine gum is a medicine and must be used a certain way to get the best results

chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is

gone, begin chewing again until the tingle returns.

repeat this process until most of the tingle is gone (about 30 minutes)

do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

if you experience strong or frequent cravings, you may use a second piece within the hour.

However, do not continuously use one piece after another since this may cause you hiccups,

heartburn, nausea or other side effects.

do not use more than 24 pieces a day

it is important to complete treatment. If you feel you need to use the gum for a longer period to keep

from smoking, talk to your health care provider.

Directions - 4 mg

if you are under 18 years of age, ask a doctor before use

before using this product, read the enclosed User's Guide for complete directions and other

important information

begin using the gum on your quit day

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum

according to the following 12 week schedule:

Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours

nicotine gum is a medicine and must be used a certain way to get the best results

chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is

gone, begin chewing again until the tingle returns.

repeat this process until most of the tingle is gone (about 30 minutes)

do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

if you experience strong or frequent cravings, you may use a second piece within the hour.

However, do not continuously use one piece after another since this may cause you hiccups,

heartburn, nausea or other side effects.

do not use more than 24 pieces a day

it is important to complete treatment. If you feel you need to use the gum for a longer period to keep

from smoking, talk to our health care provider.

Other information - 2 mg

each piece contains: calcium 115 mg, sodium 8 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Other information - 4 mg

each piece contains: calcium 120 mg, sodium 8 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Inactive ingredients - 2 mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc and

xylitol.

Inactive ingredients - 4 mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc and

xylitol.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six

weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use with a Support Program as directed in the enclosed User's Guide.

Not for sale to those under 18 years of age.

Proof of age required.

Not for sale in vending machines or from any source where proof of age cannot be verified.

Blister packaged for your protection.

Do not use if individual seals are open or torn.

Nicotine Gum 4mg Gum. square, white (off white to tan), Mint, 14mm, no score, no imprint

NDC: 70518-1048-00 30 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Rugby Nicotine Polacrilex Gum, Mint Flavor

GENERIC: Nicotine Polacrilex

DOSAGE: GUM, CHEWING

ADMINSTRATION: BUCCAL

NDC: 70518-1048-0

COLOR: white

FLAVOR: MINT

SHAPE: SQUARE

SCORE: No score

SIZE: 14 mm

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

NICOTINE 4mg in 1

INACTIVE INGREDIENT(S):

CARNAUBA WAX

MAGNESIUM OXIDE

SODIUM BICARBONATE

SODIUM CARBONATE

TALC

XYLITOL

RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR

nicotine polacrilex gum, chewing

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -10 48 (NDC:0 536 -1372)

Route of Administration

BUCCAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NICO TINE (UNII: 6 M3C8 9 ZY6 R) (NICOTINE - UNII:6 M3C8 9 ZY6 R)

NICOTINE

4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM CARBO NATE (UNII: 45P326 1C7T)

TALC (UNII: 7SEV7J4R1U)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

REMEDYREPACK INC.

Product Characteristics

Color

white (o ff-white to tan)

S core

no sco re

S hap e

SQUARE

S iz e

14mm

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:70 518 -10 48 -0

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 56 8

0 8 /14/20 19

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 6/2020

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